22 recruiting, 4 active not recruiting, 4 completed, 3 not yet recruiting. 25 Phase 2, 13 Phase 1, 5 Phase 3, 1 Early Phase 1.
Follow elacestrant: new trials by email Literature Review of elacestrant trials Research Report on elacestrant
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer Biospecimen Collection, Computed Tomography, Elacestrant - Advanced Endometrial Carcinoma, Metastatic Endometrial Carcinoma | Phase 2 | Not yet recruiting | Jonsson Comprehensive Cancer Center | 50 | 2026-12-18 | 2026-06-09 |
| Medical Imaging to Re-evaluate Elacestrant Clinical Usage Elacestrant - ER+ / HER2- Advanced Breast Cancer | Phase 2 | Not yet recruiting | Jules Bordet Institute | 160 | 2026-09-13 | 2026-08-10 |
| A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer Elacestrant - Breast Cancer | Phase 2 | Recruiting | Stemline Therapeutics, Inc. | 70 | 2026-08-18 | 2026-10-13 |
| Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer Elacestrant, Standard of care (Investigator Choice) - Breast Cancer | Recruiting | iOMEDICO AG | 500 | 2026-06-19 | 2026-06-25 | |
| Elacestrant in Advanced Triple Positive Breast Cancer Elacestrant, Trastuzumab, Pertuzumab - ER Positive, HER2 Positive Breast Cancer | Phase 1 / Phase 2 | Recruiting | NYU Langone Health | 50 | 2026-05-13 | 2026-05-28 |
| Elacestrant and Exemestane for Patients With Pretreated HR+/HER2- Metastatic Breast Cancer and [18F] FES-avid Lesions (COMBINE) elacestrant and exemestane - Breast Cancer | Phase 2 | Recruiting | European Institute of Oncology | 26 | 2026-05-11 | 2026-05-14 |
| Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC Elacestrant, Standard-of-care endocrine treatment - Breast Cancer, HR+/HER2- Breast Cancer | Phase 3 | Recruiting | Women's Cancer Study Group GmbH | 1520 | 2026-04-29 | 2026-08-07 |
| Ph 2 Elacestrant in ER Positive Uterine Sarcomas Elacestrant - Uterine Sarcoma, Uterine Leiomyosarcoma | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 30 | 2026-03-25 | 2026-05-22 |
| PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) Capecitabine, Elacestrant - Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer | Phase 2 | Recruiting | Kristina A. Fanucci | 297 | 2026-01-16 | 2026-08-26 |
| ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer Elacestrant, Trastuzumab Deruxtecan - Metastatic Breast Cancer, HER2 Low Breast Carcinoma | Phase 1 / Phase 2 | Recruiting | Kristina A. Fanucci | 65 | 2025-11-17 | 2026-06-10 |
| A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer Elacestrant, Leuprorelin - Breast Cancer | Phase 2 | Recruiting | Gustave Roussy, Cancer Campus, Grand Paris | 140 | 2025-10-06 | 2025-12-01 |
| A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer Abemaciclib, Elacestrant - Endometrial Cancer | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 75 | 2025-10-01 | 2026-07-16 |
| Circulating Tumor DNA Elacestrant - ER+ Breast Cancer | Phase 2 | Recruiting | Yale University | 50 | 2025-09-30 | 2026-09-21 |
| Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy Elacestrant, PULSAR - Breast Cancer Patients, Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Phase 2 | Not yet recruiting | Azienda Ospedaliero-Universitaria Careggi | 21 | 2025-09-01 | 2025-06-05 |
| Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Olaparib + Elacestrant, Olaparib - Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer | Phase 2 | Recruiting | GBG Forschungs GmbH | 176 | 2024-12-13 | 2025-12-01 |
| Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. Everolimus, Elacestrant, Placebo - Advanced Breast Cancer, ER-positive Breast Cancer | Phase 3 | Recruiting | MedSIR | 300 | 2024-12-05 | 2026-08-24 |
| Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer Elacestrant, DC1 native/mutated ESR1 - Breast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer | Phase 1 | Active not recruiting | H. Lee Moffitt Cancer Center and Research Institute | 18 | 2024-11-04 | 2026-08-18 |
| A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer MEN2312, Elacestrant - Advanced Breast Cancer | Phase 1 | Recruiting | Stemline Therapeutics, Inc. | 240 | 2024-10-25 | 2026-08-07 |
| A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence Elacestrant, Anastrozole, Letrozole - Breast Cancer | Phase 3 | Recruiting | Stemline Therapeutics, Inc. | 4220 | 2024-09-27 | 2026-09-15 |
| Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC ELacestrant - ESR1 Gene Mutation, Advanced Breast Cancer | Unknown | SciClone Pharmaceuticals | 350 | 2024-07-13 | 2024-08-09 |
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Breast Neoplasms (26) · Endometrial Neoplasms (2) · Adenosarcoma of the uterus (1) · Brain Diseases (1) · Brain Neoplasms (1) · Breast Diseases (1) · Breast Neoplasms, Male (1) · Carcinoma, Intraductal, Noninfiltrating (1) · Central Nervous System Diseases (1) · Central Nervous System Neoplasms (1) · Hot Flashes (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Neoplasms by Site (1) · Perivascular Epithelioid Cell Neoplasms (1)
Stemline Therapeutics, Inc. (9) · Context Therapeutics Inc. (2) · Kristina A. Fanucci (2) · SOLTI Breast Cancer Research Group (2) · Azienda Ospedaliero-Universitaria Careggi (1) · BeOne Medicines (1) · Criterium, Inc. (1) · Dana-Farber Cancer Institute (1) · Ellipses Pharma (1) · European Institute of Oncology (1) · European Organisation for Research and Treatment of Cancer - EORTC (1) · GBG Forschungs GmbH (1) · Gustave Roussy, Cancer Campus, Grand Paris (1) · H. Lee Moffitt Cancer Center and Research Institute (1) · Jonsson Comprehensive Cancer Center (1)
United States (24) · Spain (10) · France (8) · Italy (8) · Germany (7) · Belgium (6) · United Kingdom (6) · Brazil (5) · South Korea (5) · Australia (4) · Greece (4) · Argentina (3) · Austria (3) · Netherlands (3) · Portugal (3)
Kristina Fanucci, MD (2) · Aixa Soyano Muller, MD (1) · Antonio Llombart-Cussac, M.D., Ph.D. (1) · Douglas K Marks, MD (1) · Elisabeth GE de Vries, MD (1) · Emmanouil Saloustros (1) · Frances Valdes-Albini, MD (1) · Giuseppe Curigliano (1) · Jordyn Silverstein, MD (1) · Laura Esserman, MD, MBA (1)
PMID 31426673, PMID 32912274, PMID 33513026, PMID 35584336, PMID 38381994
2025 (3), 2015 (1), 2023 (1), P30CA060553 (1)